Melinta Therapeutics, LLC (Melinta) announced that the U.S. Food and Drug Administration (FDA) has approved KIMYRSA™ (oritavancin) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA). KIMYRSA is a lipoglycopeptide antibiotic that delivers a complete course of therapy for ABSSSI in a single, one hour 1,200 mg infusion. ABSSSI affect approximately 14 million patients in the U.S. each year, are responsible for over 3 million visits to the Emergency Room annually and represent the 8th most common cause of Emergency Department hospital admissions1,2. ABSSSI cost U.S. hospitals $4 billion each year, with a 4.1-day average length of stay for hospitalized ABSSSI patients. The efficacy and safety of KIMYRSA were established in the SOLO clinical trials with another oritavancin product, ORBACTIV®. The SOLO trials were randomized, double-blind, multicenter studies that evaluated a single 1,200 mg IV dose of oritavancin against twice-daily vancomycin for the treatment of ABSSSI in 1,987 adult patients and assessed one of the largest subsets of documented MRSA infection (405 patients). These trials demonstrated that 1,200 mg one-dose IV oritavancin infusion was as effective as 7-to-10 days of twice-daily vancomycin (1 g or 15 mg/kg) for the primary and secondary endpoints. KIMYRSA approval is based on the results of an open-label, multi-center, pharmacokinetics study, which compared KIMYRSA administered over 1 hour (N=50) to ORBACTIV administered over 3 hours (N=52) for the treatment of adult patients with ABSSSI. KIMYRSATM (oritavancin) is a single-dose, long-acting lipoglycopeptide antibiotic with rapid bactericidal activity for the treatment of adult patients with ABSSI caused by designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA). KIMYRSA is the first oritavancin product that is infused over one-hour, prepared from one 1,200 mg vial, and has compatibility with both 0.9% sodium chloride injection (NS) and 5% dextrose in sterile water (D5W). As an oritavancin product, KIMYRSA has three bactericidal mechanisms of action: inhibition of transpeptidation, inhibition of transglycosylation, and disruption of cell membrane integrity. KIMYRSA approval is based on the results of a pharmacokinetics (PK) study that compared KIMYRSA administered over 1 hour (N=50) to ORBACTIV® administered over 3 hours (N=52) for the treatment of adult patients with ABSSSI. The efficacy and safety of KIMYRSA were established in the SOLO clinical trials with another oritavancin product, ORBACTIV. The SOLO trials were randomized, double-blind, multicenter studies that evaluated a single 1,200 mg IV dose of oritavancin for the treatment of ABSSSI in 1,987 adult patients. These trials demonstrated that 1,200 mg one-dose IV oritavancin infusion was as effective as 7-to-10 days of twice-daily vancomycin (1 g or 15 mg/kg) for the primary and secondary endpoints. The most common adverse reactions in patients treated with oritavancin were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea. The adverse reactions occurring in =2 patients receiving KIMYRSA in the PK study were hypersensitivity, pruritus, chills and pyrexia.